Hemodialysis access with on-off functionality

• US 7,762,980 B2
• Filed: 06/19/2006
• Issued: 07/27/2010
• Est. Priority Date: 06/20/2001
• Status: Expired due to Fees

• Current Assignee: Michael Gertner
• Original Assignee: Michael Gertner
• Inventors: Gertner, Michael
• Primary Examiner(s): Zalukaeva; Tatyana
• Assistant Examiner(s): TREYGER, ILYA Y
• Application Number:
  US11/425,106
• Publication Number:
  US 20060224100A1
• Time in Patent Office: 1,499 Days
• Field of Search: 604/4.01, 604/16.16, 604/6.08, 604 501- 504, 604/6.16, 604/7.8, 604 19- 22, 604 27- 43, 604/890.1, 604/891.1, 210645-647, 210/696, 210/739, 210/745, 210/746, 210/748, 210/194, 2101951-1952, 210/252, 210/257.1, 210/257.2, 210/321.6, 210/321.71, 210/321.72, 600437-439, 600/454, 600/458.9, 600/461.2, 600/464, 600466-470, 600/11, 600/15, 606/1, 606/8, 606/10, 606 32- 34, 606/108, 606/127, 606/128, 606/195, 606/110, 607 1- 3, 607/44, 607/60, 607/61, 607/80, 607/88, 607/90, 607/94, 607 96-101, 607104-106
• US Class Current: 604/43
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/36 Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 1/3672 Means preventing coagulation
• CPC Class Codes: A61M 1/3673 Anticoagulant coating, e.g. Heparin coating

Abstract

A treatment assembly is positioned along an AV-fistula and couples therapeutic energy to an adjacent area due to a material response to an applied energy field from a remotely located energy source. The treatment assembly may be delivered into the fistula through a hemodialysis needle, or may be secured to the fistula graft itself and implanted therewith in a patient. A cover provides a shield between an anastomosis area and blood flow. Another AV-fistula includes a valved reservoir that receives a fluid agent from a hemodialysis needle while moving the needle into or from the fistula; the agent leaks from the reservoir into the fistula lumen. Another valved fistula is adjustable between an open condition and closed conditions during and between hemodialysis treatments, respectively. Another AV-fistula has a bladder reservoir coupled to a second refillable fluid reservoir and is adapted to locally deliver a therapeutic agent into the fistula lumen.

Claims

1. An AV-fistula graft, comprising:

a tubular graft body having a tubular wall extending between two opposite end portions and a lumen within the tubular wall extending along a longitudinal axis between the two opposite end portions; and

a valve system coupled to the lumen and that is adjustable between an open condition and a closed condition with respect to the lumen;

wherein in the open condition the tubular graft body is substantially adapted to allow substantial fluid communication through the tubular graft body;

wherein in the closed condition the fluid communication into the tubular graft body is substantially occluded;

wherein the valve system comprises;

first and second valves each having an expandable member coupled to the AV-fistula lumen and that is adjustable between a radially collapsed condition and a radially expanded condition;

wherein the radially collapsed condition characterizes at least in part the open condition for the valve system and allows for fluid communication between anastomoses associated with the two opposite end portions; and

wherein the radially expanded condition characterizes at least in part the closed condition for the valve system and substantially occludes fluid communication into the fistula lumen;

said first and second valves positioned along two opposite ends, respectively, of the AV-fistula graft;

wherein said first and second valves, in the closed condition, close the entire fistula from fluid communication with both of the anastomoses.

2. The graft of claim 1, wherein the two valves are adapted to be independently adjusted between the respective open and closed conditions to purge blood from the fistula.

3. The graft of claim 2, wherein the two valves are adapted to be adjusted together with a common actuator.

4. A hemodialysis method, comprising:

providing a reservoir that is adapted to couple to an AV-fistula graft;

positioning the reservoir externally around the AV-fistula graft;

wherein the AV-fistula graft is implanted within a body of a patient and extending between a first and a second anastomosis with a vein and an artery of the patient, respectively;

wherein the reservoir defines a cavity separated from fluid flow in the AV-fistula graft;

filling the reservoir with a fluid agent; and

passively eluting the fluid agent from the reservoir directly to a tissue external to the AV-fistula graft and in proximity to either of the first or second anastomosis.

5. The method of claim 4, further comprising:

eluting the fluid agent to a substantially circumferential area circumscribing a lumen of the AV-fistula graft.

6. The method of claim 4, further comprising:

substantially inhibiting formation of a stenosis associated with an AV-fistula implant along the location with the fluid eluting from the reservoir.

7. The method of claim 4, further comprising:

removing at least a portion of a stenosis associated with the AV-fistula implant with the fluid agent eluting from the reservoir.

8. The method of claim 4, further comprising:

at least in part preventing neo-intimal hyperplasia in the area with the fluid agent eluting from the reservoir.

9. The method of claim 4, further comprising inhibiting at least one of thrombogenesis or thrombus adhesion in the area with the fluid eluting from the reservoir.

10. The method of claim 4, further comprising:

securing the reservoir a tubular graft body of the AV-fistula graft;

fluidly coupling a second reservoir to the reservoir and secured to the reservoir;

storing a volume of the fluid agent within the second reservoir;

delivering the volume of the fluid agent from the second reservoir to the reservoir; and

passively eluting the volume of fluid agent from the reservoir into the tissue of the AV-fistula graft without pressurization of the reservoir.

11. The method of claim 10, further comprising:

refilling the second reservoir with a second volume of the fluid agent.

12. A method as recited in claim 4, wherein the bladder comprises a first valve adjacent an inside wall of the AV-fistula graft;

and

wherein filling the bladder reservoir comprises delivering one or more needles into the bladder through said valve and injecting the fluid agent into the reservoir.

13. A method as recited in claim 4, wherein the agent is delivered circumferentially inward onto the external tissue of the AV-fistula graft.

14. A method as recited in claim 13:

wherein the reservoir comprises a bladder having a tubular shape having an inner surface and an outer surface; and

wherein the agent is passively eluted through the inner surface of the reservoir directly onto the external tissue.

15. A method as recited in claim 14:

wherein the inner surface comprises a plurality of pores; and

wherein the agent is passively eluted through the plurality of pores.

16. A method as recited in claim 13:

wherein at least a first portion of the reservoir is configured to be positionable remote to the AV-fistula graft.

17. A method as recited in claim 13:

wherein the reservoir is coupled to a second reservoir disposed directly adjacent said AV-fistula graft,

the second reservoir having a tubular shape comprising an inner surface and an outer surface; and

wherein the agent is passively eluted through the inner surface of the reservoir directly onto the external tissue.

18. A hemodialysis method, comprising:

adjusting an AV-fistula graft, implanted within a patient and extending between an arterial and a venous anastomosis, between an open condition and a closed condition;

wherein in the open condition, the AV-fistula graft substantially allows fluid communication between the arterial anastomosis and the venous anastomosis; and

wherein in the closed condition the AV-fistula graft substantially prevents fluid communication into the AV-fistula graft between the arterial anastamosis and the venous anastomosis; and

filling a balloon within the A-V fistula graft to expand upon and engage an internal wall of the AV-fistula graft to prevent flow into the AV-fistula graft.

19. The method of claim 18, wherein the balloon is positioned at a first end of the AV-fistula graft at the arterial anastomosis, the method further comprising:

filling a second balloon within the AV-fistula graft to expand upon and engage an internal wall of the AV-fistula graft at a second, opposing end of the AV-fistula graft to prevent flow into the AV-fistula graft from either the arterial anastomosis or the venous anastomosis; and

removing blood from the AV-fistula graft in the region between the first and second expanded balloons.

20. A method as recited in claim 19, further comprising:

delivering a fluid agent inside said region of the AV-fistula graft when the AV-fistula graft is in the closed condition.

21. The method of claim 18 wherein an actuator is actuated to adjust the AV-fistula graft from the open condition to the closed condition.

22. A method as recited in claim 18, wherein the balloon is positioned at a first end of the AV-fistula graft, the method further comprising:

purging blood out of a second end opposing the first end of the AV-fistula graft after the balloon has closed the first end; and

filling a second balloon within the AV-fistula fistula graft to expand upon and engage an internal wall of the AV-fistula graft at the second end of the AV-fistula to close off the A-V fistula.

23. A method as recited in claim 18, wherein the AV-fistula graft is configured to be closed for a time period spanning the entire time between hemodialysis treatments without clotting.

24. A method as recited in claim 23, wherein said time period is at least two days.

25. A hemodialysis method, comprising:

providing a bladder reservoir that is adapted to couple to an AV-fistula graft;

coupling the bladder reservoir to the AV-fistula graft;

implanting the AV-fistula graft within a body of a patient and extending between a first and a second anastomosis with a vein and an artery of the patient, respectively;

wherein the bladder reservoir defines a cavity separated from fluid flow in the AV-fistula graft;

filling the bladder reservoir with a fluid agent; and

passively eluting the fluid agent from the bladder reservoir and into the AV-fistula graft within the patient'"'"'s body;

wherein the bladder comprises a first valve adjacent an inside wall of the AV-fistula graft and a second valve opposite said first valve, the method further comprising;

delivering at least one needle through the first valve and second valve into the A-V fistula graft;

drawing blood from the AV-fistula graft via the at least one needle to a location external to the patient'"'"'s body;

treating the blood; and

delivering the treated blood into to the AV-fistula fistula graft.

26. A method as recited in claim 25, wherein treating the blood comprises performing hemodialysis on the blood.

27. A method as recited in claim 25, wherein filling the bladder reservoir comprises proximally retracting the at least one needle into the bladder reservoir and injecting the fluid agent into the reservoir.

28. A method as recited in claim 27, wherein passively eluting fluid agent comprises leaching the fluid agent out the second valve and into the AV-fistula graft.